MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-05-16 for NIM? 2.0 MAINFRAME 8252001IP manufactured by Medtronic Xomed Inc..
[45221495]
Concomitant medical products: concomitant device: (b)(4): interface (b)(4) response 2. 0 increment, s/n (b)(4), lot 56523600 manufactured: 06/16/2008. Product evaluation: analysis results not available; no devices returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[45221496]
It was reported that the "old system is unreliable and increasingly not user-friendly. " additional information states that "they have had intermittent trouble with non-reliance on the device in regards to identifying the rln and stimulating it and getting a response on the machine visibly or audibly. " there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[102514809]
Corrected information: no eval explain code. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2016-00146 |
| MDR Report Key | 5656203 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-16 |
| Date of Report | 2016-04-19 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2008-06-13 |
| Date Added to Maude | 2016-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM? 2.0 MAINFRAME |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2016-05-16 |
| Model Number | 8252001IP |
| Catalog Number | 8252001IP |
| Lot Number | 56541200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-16 |